Intellectt INC
Location
Alpharetta, GA | United States
Job description
Job Title: Compliant Investigation Specialist II
Location: 5405 Windward Pkwy, Alpharetta, GA 30004, United States
Duration: 06 MONTHS.
100% Onsite Role - TEMP TO HIRE
Description:
The major purpose of this position is to support the on-going activities required to support the assigned product family activities. These activities include but are not limited to:
Investigation of customer complaints
Review of customer complaint trends
Support and participate in complaint process improvement initiatives
Job Position Scope (Optional)
The scope of the Quality Assurance Specialist position is to:
Efficiently performing Complaint Handling (Investigations and/or Approvals) and Failure Investigation (Quality Assurance)
Communicate complaint status, and challenges effectively to project team(s)
Job Position Accountabilities / Expectations
Develop and document customer complaint investigations.
Identification and risk management of customer complaints.
Evaluate, document, and communicate customer complaint trends.
Analyze reports of defects and process issues to determine trends.
Analyze trends and identify potential root causes
Conduct statistical analyses and document resulting risk analyses
Ensure that the applicable procedures are put into practice correctly. If lack of clarity is identified in procedures, report and promote the pertinent changes for clarification.
Recommendation for improvement of procedures as applicable.
Coordinate and/or train on new or modified procedures.
Participate in cross-functional continuous improvement projects or teams.
Key Relationships / Customer Expectations (Optional)
The Key Relationships / Customer Expectations of Complaint Investigation Specialist position is to understand all levels of management within Technical Quality, Quality Systems, Global Post-Market Surveillance, Research & Development, and Project Management
Key Leadership Values (Optional)
The Key Leadership Values of the Complaint Investigation Specialist position is to:
Conduct self in accordance with the expected approved Corporate values.
Motivated to promote and achieve goals in-line with project leadership and targets.
Qualifications / Education / Experience (Required)
B.S. in Quality Assurance or Quality Systems with a minimum of 4-7 years of collective experience in a medical device required:
Experience in Complaint Investigation and assessing patient risk
Experience writing conclusions of root cause analysis, summaries of complaint investigations, and communicating results
Proficient with Microsoft Office programs
Presentation Creation
Specialized or Essential Knowledge (Preferred)
Experience in Quality Systems (ISO 13485), Risk Management (ISO 14971), Auditing, Complaint Handling, Corrective, and Preventative Actions (CAPA)
Excel user comfortable creating pivot tables
Job tags
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